{"id":"capmatinib","rwe":[{"pmid":"41654096","year":"2026","title":"Real-world evidence for 10 oncology drugs approved in the last 5 years: A comprehensive narrative synthesis.","finding":"","journal":"Critical reviews in oncology/hematology","studyType":"Clinical Study"},{"pmid":"41617462","year":"2026","title":"Clinical Activity of MET-TKIs in METex14 Skipping NSCLC With Poor Performance Status.","finding":"","journal":"Anticancer research","studyType":"Clinical Study"},{"pmid":"41595127","year":"2026","title":"Targeting Mesenchymal-Epidermal Transition (MET) Aberrations in Non-Small Cell Lung Cancer: Current Challenges and Therapeutic Advances.","finding":"","journal":"Cancers","studyType":"Clinical Study"},{"pmid":"41582009","year":"2026","title":"A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk.","finding":"","journal":"Renal failure","studyType":"Clinical Study"},{"pmid":"41573491","year":"2025","title":"Safety and Synergy of Capmatinib Plus Stereotactic Radiotherapy in MET Exon 14-Mutated Non-Small Cell Lung Cancer: A Case Report.","finding":"","journal":"Cureus","studyType":"Clinical Study"}],"_fda":{"id":"0df064bb-358d-4c21-8525-9b8b9a5845a1","set_id":"455892c3-d144-4ba8-9ab4-79cabff9876d","openfda":{"unii":["C2A374O70X"],"route":["ORAL"],"rxcui":["2362234","2362240","2362242","2362244"],"spl_id":["0df064bb-358d-4c21-8525-9b8b9a5845a1"],"brand_name":["TABRECTA"],"spl_set_id":["455892c3-d144-4ba8-9ab4-79cabff9876d"],"package_ndc":["0078-0709-56","0078-0709-94","0078-0716-56","0078-0716-94"],"product_ndc":["0078-0709","0078-0716"],"generic_name":["CAPMATINIB"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CAPMATINIB HYDROCHLORIDE"],"manufacturer_name":["Novartis Pharmaceuticals Corporation"],"application_number":["NDA213591"],"is_original_packager":[true]},"version":"17","pregnancy":["8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , TABRECTA can cause fetal harm when administered to a pregnant woman. There are no available data on TABRECTA use in pregnant women. Oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures less than the human exposure based on AUC at the 400 mg twice daily clinical dose ( see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In rats, maternal toxicity (reduced body weight gain and food consumption) occurred at 30 mg/kg/day (approximately 1.4 times the human exposure based on AUC at the 400 mg twice daily clinical dose). Fetal effects included reduced fetal weights, irregular/incomplete ossification, and increased incidences of fetal malformations (e.g., abnormal flexure/inward malrotation of hindpaws/forepaws, thinness of forelimbs, lack of/reduced flexion at the humerus/ulna joints, and narrowed or small tongue) at doses of ≥ 10 mg/kg/day (approximately 0.6 times the human exposure based on AUC at the 400 mg twice daily clinical dose). In rabbits, no maternal effects were detected at doses up to 60 mg/kg/day (approximately 1.5 times the human exposure based on AUC at the 400 mg twice daily clinical dose). Fetal effects included small lung lobe at ≥ 5 mg/kg/day (approximately 0.016 times the human exposure based on AUC at the 400 mg twice daily clinical dose), and reduced fetal weights, irregular/incomplete ossification and increased incidences of fetal malformations (e.g., abnormal flexure/malrotation of hindpaws/forepaws, thinness of forelimbs/hindlimbs, lack of/reduced flexion at the humerus/ulna joints, small lung lobes, narrowed or small tongue) at the dose of 60 mg/kg/day."],"description":["11 DESCRIPTION Capmatinib is a kinase inhibitor. The chemical name is 2-Fluoro- N -methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2- b ][1,2,4]triazin-2-yl]benzamide—hydrogen chloride—water (1/2/1). The molecular formula for capmatinib dihydrochloride monohydrate is C 23 H 21 Cl 2 FN 6 O 2 . The relative molecular mass is 503.36 g/mol for the dihydrochloride monohydrate salt and 412.43 g/mol for the free base. The chemical structure for capmatinib dihydrochloride monohydrate is shown below: Capmatinib dihydrochloride monohydrate is a yellow powder with a pKa 1 of 0.9 (calculated) and pKa 2 of 4.5 (experimentally). Capmatinib dihydrochloride monohydrate is slightly soluble in acidic aqueous solutions at pH 1 and 2 and of further decreasing solubility towards neutral condition. The log of the distribution coefficient (n-octanol/acetate buffer pH 4.0) is 1.2. TABRECTA is supplied for oral use as ovaloid, curved film-coated tablets with beveled edges, unscored containing 150 mg (pale orange brown color) or 200 mg (yellow color) capmatinib (equivalent to 183.00 mg or 244.00 mg respectively of capmatinib dihydrochloride monohydrate). Each tablet strength contains colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate as inactive ingredients. The 150 mg tablet coating contains ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. The 200 mg tablet coating contains ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. capmatinib dihydrochloride monohydrate structural formula"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TABRECTA (capmatinib) 150 mg and 200 mg tablets Strength Description Tablets per bottle NDC number 150 mg Pale orange brown, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘DU’ on one side and ‘NVR’ on the other side. 56 0078-0709-56 200 mg Yellow, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘LO’ on one side and ‘NVR’ on the other side. 56 0078-0716-56 Storage Dispense in the original package with the desiccant cartridge. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Discard any unused TABRECTA remaining after 6 weeks of first opening the bottle."],"geriatric_use":["8.5 Geriatric Use In GEOMETRY mono-1, 61% of the 373 patients were 65 years or older and 18% were 75 years or older. No overall differences in the safety or effectiveness were observed between these patients and younger patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of TABRECTA in pediatric patients have not been established."],"effective_time":"20251215","clinical_studies":["14 CLINICAL STUDIES Metastatic NSCLC with a Mutation that Leads to MET Exon 14 Skipping The efficacy of TABRECTA was evaluated in GEOMETRY mono-1, a multicenter, non-randomized, open-label, multi-cohort study (NCT02414139). Eligible patients were required to have NSCLC with a mutation that leads to MET exon 14 skipping, epidermal growth factor receptor (EGFR) wild-type and anaplastic lymphoma kinase (ALK) negative status, and at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients with symptomatic CNS metastases, clinically significant uncontrolled cardiac disease, or who received treatment with any MET or hepatocyte growth factor (HGF) inhibitor were not eligible for the study. Out of the first 97 patients enrolled in GEOMETRY mono-1 following the central confirmation of MET exon 14 skipping by a RNA-based clinical trial assay, 78 patient samples were retested with the FDA-approved FoundationOne ® CDx (22 treatment-naïve and 56 previously treated patients) to detect mutations that lead to MET exon 14 skipping. Out of 78 samples retested with FoundationOne ® CDx, 73 samples were evaluable (20 treatment-naïve and 53 previously treated patients), 72 (20 treatment-naïve and 52 previously treated patients) of which were confirmed to have a mutation that leads to MET exon 14 skipping, demonstrating an estimated positive percentage agreement of 99% (72/73) between the clinical trial assay and the FDA-approved assay. Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall response rate (ORR) as determined by a Blinded Independent Review Committee (BIRC) according to RECIST 1.1. An additional efficacy outcome measure was duration of response (DOR) by BIRC. The efficacy population included 60 treatment-naïve patients and 100 previously treated patients. The median age was 71 years (range: 48 to 90 years); 61% female; 77% White; 25% had Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 and 74% had ECOG PS 1; 61% never smoked; 83% had adenocarcinoma; and 16% had CNS metastases. Among previously treated patients, 81% received one, 16% received two and 3% received three prior lines of systemic therapy. Amongst previously treated patients, 86% received prior platinum-based chemotherapy. Efficacy results are presented in Table 5. Table 5: Efficacy Results for Treatment-Naïve and Previously Treated Patients in GEOMETRY mono-1 Abbreviations: CI, confidence interval; NE, not estimable. a Blinded Independent Review Committee (BIRC) review. b Confirmed response. c Clopper and Pearson exact binomial 95% CI. d Based on Kaplan-Meier estimate. Efficacy parameters Treatment-naïve N = 60 Previously treated N = 100 Overall response rate a,b (95% CI) c 68% (55, 80) 44% (34, 54) Complete response 5% 0 Partial response 63% 44% Duration of response (DOR) a Median (months) (95% CI) d 16.6 (8.4, 22.1) 9.7 (5.6, 13.0) Patients % with DOR ≥ 12 months 49% 36%"],"pharmacodynamics":["12.2 Pharmacodynamics Exposure-Response Capmatinib exposure-response relationships and the time course of pharmacodynamics response are unknown. Cardiac Electrophysiology No large mean increase in QTc (i.e. > 20 ms) was detected following treatment with TABRECTA at the recommended dosage of 400 mg orally twice daily."],"pharmacokinetics":["12.3 Pharmacokinetics Capmatinib exposure (AUC 0-12h and C max ) increased approximately proportionally over a dose range of 200 mg (0.5 times the recommended dosage) to 400 mg. Capmatinib reached steady-state by day 3 following twice daily dosing, with a mean (% coefficient of variation [%CV]) accumulation ratio of 1.5 (41%). Absorption After administration of TABRECTA 400 mg orally in patients with cancer, capmatinib peak plasma concentrations (C max ) were reached in approximately 1 to 2 hours (T max ). The absorption of capmatinib after oral administration is estimated to be greater than 70%. Effect of Food A high-fat meal (containing approximately 1000 calories and 50% fat) in healthy subjects increased capmatinib AUC 0-INF by 46% with no change in C max compared to under fasted conditions. A low-fat meal (containing approximately 300 calories and 20% fat) in healthy subjects had no clinically meaningful effect on capmatinib exposure. When capmatinib was administered at 400 mg orally twice daily in cancer patients, exposure (AUC 0-12h ) was similar after administration of capmatinib with food and under fasted conditions. Distribution Capmatinib plasma protein binding is 96%, independent of capmatinib concentration. The apparent mean volume of distribution at steady-state is 164 L. The blood-to-plasma ratio was 1.5, but decreased at higher concentrations to 0.9. Elimination The effective elimination half-life of capmatinib is 6.5 hours. The mean (%CV) steady-state apparent clearance of capmatinib is 24 L/hr (82%). Metabolism Capmatinib is primarily metabolized by CYP3A4 and aldehyde oxidase. Excretion Following a single oral administration of radiolabeled-capmatinib to healthy subjects, 78% of the total radioactivity was recovered in feces with 42% as unchanged and 22% was recovered in urine with negligible as unchanged. Specific Populations No clinically significant effects on the pharmacokinetic parameters of capmatinib were identified for the following covariates assessed: age (26 to 90 years), sex, race (White, Asian, Native American, Black, unknown), body weight (35 to 131 kg), mild to moderate renal impairment (baseline CLcr 30 to 89 mL/min by Cockcroft-Gault) and mild, moderate or severe hepatic impairment (Child-Pugh classification). The effect of severe renal impairment (baseline CLcr 15 to 29 mL/min) on capmatinib pharmacokinetics has not been studied. Drug Interaction Studies Clinical Studies and Model-Informed Approaches Strong CYP3A Inhibitors: Coadministration with itraconazole (a strong CYP3A inhibitor) increased capmatinib AUC 0-INF by 42% with no change in capmatinib C max . Strong CYP3A Inducers: Coadministration with rifampicin (a strong CYP3A inducer) decreased capmatinib AUC 0-INF by 67% and decreased C max by 56%. Moderate CYP3A Inducers: Coadministration with efavirenz (a moderate CYP3A inducer) was predicted to decrease capmatinib AUC 0-12h by 44% and decrease C max by 34%. Proton Pump Inhibitors: Coadministration with rabeprazole (a proton pump inhibitor) decreased capmatinib AUC 0-INF by 25% and decreased C max by 38%. Substrates of CYP Enzymes: Coadministration of capmatinib increased caffeine (a CYP1A2 substrate) AUC 0-INF by 134% with no change in its C max . Coadministration of capmatinib had no clinically meaningful effect on exposure of midazolam (a CYP3A substrate). P-gp Substrates: Coadministration of capmatinib increased digoxin (a P-gp substrate) AUC 0-INF by 47% and increased C max by 74%. BCRP Substrates: Coadministration of capmatinib increased rosuvastatin (a BCRP substrate) AUC 0-INF by 108% and increased C max by 204%. In Vitro Studies Transporter Systems: Capmatinib is a substrate of P-gp, but not a substrate of BCRP or MRP2. Capmatinib reversibly inhibits MATE1 and MATE2K, but does not inhibit OATP1B1, OATP1B3, OCT1, OAT1, OAT3, or MRP2."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: ILD/Pneumonitis [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Pancreatic Toxicity [see Warnings and Precautions (5.3)] Hypersensitivity reactions [see Warnings and Precautions (5.4)] The most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metastatic Non-Small Cell Lung Cancer The safety of TABRECTA was evaluated in GEOMETRY mono-1 [see Clinical Studies (14)] . Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity (N = 373). Among patients who received TABRECTA, 37% were exposed for at least 6 months and 22% were exposed for at least one year. Serious adverse reactions occurred in 53% of patients who received TABRECTA. Serious adverse reactions in ≥ 2% of patients included dyspnea (7%), pneumonia (7%), pleural effusion (4.3%), musculoskeletal pain (3.8%), general physical health deterioration (2.9%), ILD/pneumonitis (2.7%), edema (2.4%), and vomiting (2.4%). Fatal adverse reactions occurred in 0.5% of patients who received TABRECTA, including pneumonitis (0.3%) and death, not otherwise specified (0.3%). Permanent discontinuation of TABRECTA due to an adverse reaction occurred in 17% of patients. The most frequent adverse reactions (≥ 1%) leading to permanent discontinuation of TABRECTA were ILD/pneumonitis (2.4%), edema (2.4%), fatigue (1.3%), and pneumonia (1.1%). Dose interruptions due to an adverse reaction occurred in 57% of patients who received TABRECTA. Adverse reactions requiring dosage interruption in > 2% of patients who received TABRECTA included edema, increased blood creatinine, nausea, increased lipase, vomiting, increased ALT, dyspnea, pneumonia, fatigue, increased amylase, increased AST, musculoskeletal pain, abdominal pain, and increased blood bilirubin. Dose reductions due to an adverse reaction occurred in 26% of patients who received TABRECTA. Adverse reactions requiring dosage reductions in > 2% of patients who received TABRECTA included edema, increased ALT and increased blood creatinine. The most common adverse reactions (≥ 20%) in patients who received TABRECTA were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite. Table 3 summarizes the adverse reactions in GEOMETRY mono-1. Table 3: Adverse Reactions (≥ 10%) in Patients Who Received TABRECTA in GEOMETRY mono-1 a Edema includes edema peripheral, generalized edema, face edema, edema, localized edema, edema genital, eyelid edema, peripheral swelling, scrotal edema, and penile edema. b Musculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, pain in jaw, spinal pain. c Fatigue includes fatigue and asthenia. d Pyrexia includes pyrexia and body temperature increased. e Cough includes cough, upper airway cough syndrome, and productive cough. f Pneumonia includes pneumonia aspiration, pneumonia, pneumonia influenzal, pneumonia bacterial, lower respiratory tract infection, and lung abscess. g Rash includes rash, dermatitis acneiform, rash maculo-papular, eczema, erythema multiforme, rash macular, dermatitis, rash erythematous, rash pustular, dermatitis bullous, and rash vesicular. h Dizziness includes dizziness, vertigo, and vertigo positional. Adverse reactions TABRECTA (N = 373) Grades 1 to 4 (%) Grades 3 to 4 (%) General disorders and administration-site conditions Edema a 59 13 Musculoskeletal pain b 40 4.3 Fatigue c 34 8 Pyrexia d 14 0.8 Weight decreased 11 0.5 Gastrointestinal disorders Nausea 46 2.4 Vomiting 28 2.4 Constipation 19 0.8 Diarrhea 19 0.5 Respiratory, thoracic, and mediastinal disorders Dyspnea 25 7 Cough e 21 0.5 Pneumonia f 13 6 Metabolism and nutrition disorders Decreased appetite 21 1.1 Skin and subcutaneous tissue disorders Rash g 13 0.5 Nervous system disorders Dizziness h 13 0.5 Clinically relevant adverse reactions occurring in < 10% of patients treated with TABRECTA included pruritus (including allergic pruritus), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis. Table 4 summarizes the laboratory abnormalities in GEOMETRY mono-1. Table 4: Select Laboratory Abnormalities (≥ 20%) Worsening From Baseline in Patients Who Received TABRECTA in GEOMETRY mono-1 a The denominator used to calculate the rate varied from 359 to 364 based on the number of patients with a baseline value and at least one post-treatment value. Laboratory abnormalities TABRECTA a Grades 1 to 4 (%) Grades 3 to 4 (%) Chemistry Decreased albumin 72 1.9 Increased creatinine 65 0.5 Increased alanine aminotransferase 39 9 Increased amylase 34 4.7 Increased alkaline phosphatase 32 0.6 Increased gamma-glutamyltransferase 30 6 Increased lipase 29 9 Increased aspartate aminotransferase 28 6 Decreased phosphate 26 4.4 Increased potassium 25 4.1 Decreased sodium 24 6 Decreased glucose 23 0.3 Hematology Decreased lymphocytes 45 14 Decreased leukocytes 25 1.7 Decreased hemoglobin 24 2.8 Other Clinical Trials Experience The following adverse reactions have been reported following administration of TABRECTA: hypersensitivity and thrombocytopenia."],"contraindications":["4 CONTRAINDICATIONS None. None."],"drug_interactions":["7 DRUG INTERACTIONS Strong and Moderate CYP3A Inducers : Avoid concomitant use. ( 7.1 ) 7.1 Effect of Other Drugs on TABRECTA Strong CYP3A Inhibitors Coadministration of TABRECTA with a strong CYP3A inhibitor increased capmatinib exposure, which may increase the incidence and severity of adverse reactions of TABRECTA [see Clinical Pharmacology (12.3)] . Closely monitor patients for adverse reactions during coadministration of TABRECTA with strong CYP3A inhibitors. Strong and Moderate CYP3A Inducers Coadministration of TABRECTA with a strong CYP3A inducer decreased capmatinib exposure. Coadministration of TABRECTA with a moderate CYP3A inducer may also decrease capmatinib exposure. Decreases in capmatinib exposure may decrease TABRECTA anti-tumor activity [see Clinical Pharmacology (12.3)] . Avoid coadministration of TABRECTA with strong and moderate CYP3A inducers. 7.2 Effect of TABRECTA on Other Drugs CYP1A2 Substrates Coadministration of TABRECTA increased the exposure of a CYP1A2 substrate, which may increase the adverse reactions of these substrates [see Clinical Pharmacology (12.3)] . If coadministration is unavoidable between TABRECTA and CYP1A2 substrates where minimal concentration changes may lead to serious adverse reactions, decrease the CYP1A2 substrate dosage in accordance with the approved prescribing information. P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) Substrates Coadministration of TABRECTA increased the exposure of a P-gp substrate and a BCRP substrate, which may increase the adverse reactions of these substrates [see Clinical Pharmacology (12.3)] . If coadministration is unavoidable between TABRECTA and P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions, decrease the P-gp or BCRP substrate dosage in accordance with the approved prescribing information. MATE1 and MATE2K Substrates Coadministration of TABRECTA may increase the exposure of MATE1 and MATE2K substrates, which may increase the adverse reactions of these substrates [see Clinical Pharmacology (12.3)] . If coadministration is unavoidable between TABRECTA and MATE1 or MATE2K substrates where minimal concentration changes may lead to serious adverse reactions, decrease the MATE1 or MATE2K substrate dosage in accordance with the approved prescribing information."],"how_supplied_table":["
TABRECTA (capmatinib) 150 mg and 200 mg tablets
StrengthDescriptionTablets per bottleNDC number
150 mgPale orange brown, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘DU’ on one side and ‘NVR’ on the other side.560078-0709-56
200 mgYellow, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘LO’ on one side and ‘NVR’ on the other side.560078-0716-56
"],"mechanism_of_action":["12.1 Mechanism of Action Capmatinib is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling. Capmatinib inhibited cancer cell growth driven by a mutant MET variant lacking exon 14 at clinically achievable concentrations and demonstrated anti-tumor activity in murine tumor xenograft models derived from human lung tumors with either a mutation leading to MET exon 14 skipping or MET amplification. Capmatinib inhibited the phosphorylation of MET triggered by binding of hepatocyte growth factor or by MET amplification, as well as MET-mediated phosphorylation of downstream signaling proteins and proliferation and survival of MET-dependent cancer cells."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Capmatinib is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling. Capmatinib inhibited cancer cell growth driven by a mutant MET variant lacking exon 14 at clinically achievable concentrations and demonstrated anti-tumor activity in murine tumor xenograft models derived from human lung tumors with either a mutation leading to MET exon 14 skipping or MET amplification. Capmatinib inhibited the phosphorylation of MET triggered by binding of hepatocyte growth factor or by MET amplification, as well as MET-mediated phosphorylation of downstream signaling proteins and proliferation and survival of MET-dependent cancer cells. 12.2 Pharmacodynamics Exposure-Response Capmatinib exposure-response relationships and the time course of pharmacodynamics response are unknown. Cardiac Electrophysiology No large mean increase in QTc (i.e. > 20 ms) was detected following treatment with TABRECTA at the recommended dosage of 400 mg orally twice daily. 12.3 Pharmacokinetics Capmatinib exposure (AUC 0-12h and C max ) increased approximately proportionally over a dose range of 200 mg (0.5 times the recommended dosage) to 400 mg. Capmatinib reached steady-state by day 3 following twice daily dosing, with a mean (% coefficient of variation [%CV]) accumulation ratio of 1.5 (41%). Absorption After administration of TABRECTA 400 mg orally in patients with cancer, capmatinib peak plasma concentrations (C max ) were reached in approximately 1 to 2 hours (T max ). The absorption of capmatinib after oral administration is estimated to be greater than 70%. Effect of Food A high-fat meal (containing approximately 1000 calories and 50% fat) in healthy subjects increased capmatinib AUC 0-INF by 46% with no change in C max compared to under fasted conditions. A low-fat meal (containing approximately 300 calories and 20% fat) in healthy subjects had no clinically meaningful effect on capmatinib exposure. When capmatinib was administered at 400 mg orally twice daily in cancer patients, exposure (AUC 0-12h ) was similar after administration of capmatinib with food and under fasted conditions. Distribution Capmatinib plasma protein binding is 96%, independent of capmatinib concentration. The apparent mean volume of distribution at steady-state is 164 L. The blood-to-plasma ratio was 1.5, but decreased at higher concentrations to 0.9. Elimination The effective elimination half-life of capmatinib is 6.5 hours. The mean (%CV) steady-state apparent clearance of capmatinib is 24 L/hr (82%). Metabolism Capmatinib is primarily metabolized by CYP3A4 and aldehyde oxidase. Excretion Following a single oral administration of radiolabeled-capmatinib to healthy subjects, 78% of the total radioactivity was recovered in feces with 42% as unchanged and 22% was recovered in urine with negligible as unchanged. Specific Populations No clinically significant effects on the pharmacokinetic parameters of capmatinib were identified for the following covariates assessed: age (26 to 90 years), sex, race (White, Asian, Native American, Black, unknown), body weight (35 to 131 kg), mild to moderate renal impairment (baseline CLcr 30 to 89 mL/min by Cockcroft-Gault) and mild, moderate or severe hepatic impairment (Child-Pugh classification). The effect of severe renal impairment (baseline CLcr 15 to 29 mL/min) on capmatinib pharmacokinetics has not been studied. Drug Interaction Studies Clinical Studies and Model-Informed Approaches Strong CYP3A Inhibitors: Coadministration with itraconazole (a strong CYP3A inhibitor) increased capmatinib AUC 0-INF by 42% with no change in capmatinib C max . Strong CYP3A Inducers: Coadministration with rifampicin (a strong CYP3A inducer) decreased capmatinib AUC 0-INF by 67% and decreased C max by 56%. Moderate CYP3A Inducers: Coadministration with efavirenz (a moderate CYP3A inducer) was predicted to decrease capmatinib AUC 0-12h by 44% and decrease C max by 34%. Proton Pump Inhibitors: Coadministration with rabeprazole (a proton pump inhibitor) decreased capmatinib AUC 0-INF by 25% and decreased C max by 38%. Substrates of CYP Enzymes: Coadministration of capmatinib increased caffeine (a CYP1A2 substrate) AUC 0-INF by 134% with no change in its C max . Coadministration of capmatinib had no clinically meaningful effect on exposure of midazolam (a CYP3A substrate). P-gp Substrates: Coadministration of capmatinib increased digoxin (a P-gp substrate) AUC 0-INF by 47% and increased C max by 74%. BCRP Substrates: Coadministration of capmatinib increased rosuvastatin (a BCRP substrate) AUC 0-INF by 108% and increased C max by 204%. In Vitro Studies Transporter Systems: Capmatinib is a substrate of P-gp, but not a substrate of BCRP or MRP2. Capmatinib reversibly inhibits MATE1 and MATE2K, but does not inhibit OATP1B1, OATP1B3, OCT1, OAT1, OAT3, or MRP2."],"indications_and_usage":["1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue TABRECTA in patients with ILD/pneumonitis. ( 2.3 , 5.1 ) Hepatotoxicity : Monitor liver function tests. Withhold, dose reduce, or permanently discontinue TABRECTA based on severity. ( 2.3 , 5.2 ) Pancreatic Toxicity : Monitor amylase and lipase levels. Withhold, dose reduce, or permanently discontinue TABRECTA based on severity. ( 2.3 , 5.3 ) Hypersensitivity Reactions : Withhold or permanently discontinue TABRECTA based on severity. ( 2.3 , 5.4 ) Risk of Photosensitivity : May cause photosensitivity reactions. Advise patients to limit direct ultraviolet exposure. ( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD)/Pneumonitis ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA [see Adverse Reactions (6.1)] . ILD/pneumonitis occurred in 4.8% of patients treated with TABRECTA in GEOMETRY mono-1, with 1.9% of patients experiencing Grade 3 ILD/pneumonitis and one patient experiencing death (0.3%). Nine patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis. The median time-to-onset of Grade 3 or higher ILD/pneumonitis was 1.8 months (range: 0.2 months to 1.7 years). Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administration (2.3)] . 5.2 Hepatotoxicity Hepatotoxicity occurred in patients treated with TABRECTA [see Adverse Reactions (6.1)] . Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 15% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 7% of patients. Three patients (0.8%) discontinued TABRECTA due to increased ALT/AST. The median time-to-onset of Grade 3 or higher increased ALT/AST was 1.8 months (range: 0.5 to 46.4 months). Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TABRECTA, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TABRECTA [see Dosage and Administration (2.3)] . 5.3 Pancreatic Toxicity Elevations in amylase and lipase levels occurred in patients treated with TABRECTA [see Adverse Reactions (6.1)] . Increased amylase/lipase occurred in 14% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 and 4 increased amylase/lipase occurred in 7% and 1.9% of patients, respectively. Three patients (0.8%) discontinued TABRECTA due to increased amylase/lipase. The median time-to-onset of Grade 3 or higher increased amylase/lipase was 2 months (range: 0.03 to 31.1 months). Pancreatitis (Grade 3) occurred in one patient (0.3%); TABRECTA was permanently discontinued for this event. Monitor amylase and lipase at baseline and regularly during treatment with TABRECTA. Based on the severity of the adverse reaction, temporarily withhold, dose reduce, or permanently discontinue TABRECTA [see Dosage and Administration (2.3)] . 5.4 Hypersensitivity Reactions Serious hypersensitivity reactions occurred in patients treated with TABRECTA in clinical trials other than GEOMETRY mono-1 [see Adverse Reactions (6.1)] . Signs and symptoms of hypersensitivity included pyrexia, chills, pruritus, rash, decreased blood pressure, nausea and vomiting. Based on the severity of the adverse reaction, temporarily withhold or permanently discontinue TABRECTA [see Dosage and Administration (2.3)] . 5.5 Risk of Photosensitivity Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA [see Nonclinical Toxicology (13.2)] . In GEOMETRY mono-1, it was recommended that patients use precautionary measures against ultraviolet exposure such as use of sunscreen or protective clothing during treatment with TABRECTA. Advise patients to limit direct ultraviolet exposure during treatment with TABRECTA. 5.6 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, TABRECTA can cause fetal harm when administered to a pregnant woman. Oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at exposures less than the human exposure based on area under the curve (AUC) at the 400 mg twice daily clinical dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.1, 8.3)] ."],"clinical_studies_table":["
Table 5: Efficacy Results for Treatment-Naïve and Previously Treated Patients in GEOMETRY mono-1
Abbreviations: CI, confidence interval; NE, not estimable. aBlinded Independent Review Committee (BIRC) review. bConfirmed response. cClopper and Pearson exact binomial 95% CI. dBased on Kaplan-Meier estimate.
Efficacy parametersTreatment-naïve N = 60Previously treated N = 100
Overall response ratea,b (95% CI)c68% (55, 80)44% (34, 54)
Complete response5%0
Partial response63%44%
Duration of response (DOR)a
Median (months) (95% CI)d16.6 (8.4, 22.1)9.7 (5.6, 13.0)
Patients % with DOR ≥ 12 months49%36%
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies were not conducted with capmatinib. Capmatinib was not mutagenic in an in vitro bacterial reverse mutation assay and did not cause chromosomal aberrations in an in vitro chromosome aberration assay in human peripheral blood lymphocytes. Capmatinib was not clastogenic in an in vivo bone marrow micronucleus test in rats. Dedicated fertility studies were not conducted with capmatinib. No effects on male and female reproductive organs occurred in general toxicology studies conducted in rats and monkeys at doses resulting in exposures of up to approximately 3.6 times the human exposure based on AUC at the 400 mg twice daily clinical dose. 13.2 Animal Toxicology and/or Pharmacology In rats, capmatinib administration resulted in vacuolation of white matter of the brain in both 4- and 13-week studies at doses ≥ 2.2 times the human exposure (AUC) at the 400 mg twice daily clinical dose. In some cases, the brain lesions were associated with early death and/or convulsions or tremors. Concentrations of capmatinib in the brain tissue of rats was approximately 9% of the corresponding concentrations in plasma. In vitro and in vivo assays demonstrated that capmatinib has some potential for photosensitization; however, the no-observed-adverse-effect level for in vivo photosensitization was 30 mg/kg/day (C max of 14000 ng/mL), about 2.9 times the human C max at the 400 mg twice daily clinical dose."],"adverse_reactions_table":["
Table 3: Adverse Reactions (≥ 10%) in Patients Who Received TABRECTA in GEOMETRY mono-1
aEdema includes edema peripheral, generalized edema, face edema, edema, localized edema, edema genital, eyelid edema, peripheral swelling, scrotal edema, and penile edema. bMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, pain in jaw, spinal pain. cFatigue includes fatigue and asthenia. dPyrexia includes pyrexia and body temperature increased. eCough includes cough, upper airway cough syndrome, and productive cough. fPneumonia includes pneumonia aspiration, pneumonia, pneumonia influenzal, pneumonia bacterial, lower respiratory tract infection, and lung abscess. gRash includes rash, dermatitis acneiform, rash maculo-papular, eczema, erythema multiforme, rash macular, dermatitis, rash erythematous, rash pustular, dermatitis bullous, and rash vesicular. hDizziness includes dizziness, vertigo, and vertigo positional.
Adverse reactionsTABRECTA (N = 373)
Grades 1 to 4 (%)Grades 3 to 4 (%)
General disorders and administration-site conditions
Edemaa5913
Musculoskeletal painb404.3
Fatiguec348
Pyrexiad140.8
Weight decreased110.5
Gastrointestinal disorders
Nausea 462.4
Vomiting 282.4
Constipation 190.8
Diarrhea 190.5
Respiratory, thoracic, and mediastinal disorders
Dyspnea257
Coughe210.5
Pneumoniaf136
Metabolism and nutrition disorders
Decreased appetite211.1
Skin and subcutaneous tissue disorders
Rashg130.5
Nervous system disorders
Dizzinessh130.5
","
Table 4: Select Laboratory Abnormalities (≥ 20%) Worsening From Baseline in Patients Who Received TABRECTA in GEOMETRY mono-1
aThe denominator used to calculate the rate varied from 359 to 364 based on the number of patients with a baseline value and at least one post-treatment value.
Laboratory abnormalitiesTABRECTAa
Grades 1 to 4 (%)Grades 3 to 4 (%)
Chemistry
Decreased albumin721.9
Increased creatinine650.5
Increased alanine aminotransferase399
Increased amylase344.7
Increased alkaline phosphatase320.6
Increased gamma-glutamyltransferase306
Increased lipase299
Increased aspartate aminotransferase286
Decreased phosphate264.4
Increased potassium254.1
Decreased sodium246
Decreased glucose230.3
Hematology
Decreased lymphocytes 4514
Decreased leukocytes 251.7
Decreased hemoglobin 242.8
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Interstitial Lung Disease (ILD)/Pneumonitis Inform patients of the risks of severe or fatal ILD/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms [see Warnings and Precautions (5.1)] . Hepatotoxicity Inform patients that they will need to undergo lab tests to monitor liver function. Advise patients to immediately contact their healthcare provider for signs and symptoms of liver dysfunction [see Warnings and Precautions (5.2)] . Pancreatic Toxicity Inform patients that they will need to undergo lab tests to monitor pancreatic function. Advise patients to immediately contact their healthcare provider for signs and symptoms of pancreatitis [see Warnings and Precautions (5.3)] . Hypersensitivity Reactions Inform patients that there is a risk of hypersensitivity reactions with TABRECTA. Advise patients to stop taking TABRECTA and immediately contact their healthcare provider for signs and symptoms of hypersensitivity [see Warnings and Precautions (5.4)] . Risk of Photosensitivity Inform patients that there is a potential risk of photosensitivity reactions with TABRECTA. Advise patients to limit direct ultraviolet exposure by using sunscreen or protective clothing during treatment with TABRECTA [see Warnings and Precautions (5.5)] . Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.3)] . Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.3)] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)] . Lactation Advise women not to breastfeed during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.2)] . Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2024-19"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Select patients for treatment with TABRECTA based on presence of a mutation that leads to MET exon 14 skipping. ( 2.1 ) Recommended Dosage : 400 mg orally twice daily with or without food. ( 2.2 ) 2.1 Patient Selection Select patients for treatment with TABRECTA based on the presence of a mutation that leads to MET exon 14 skipping in tumor or plasma specimens [see Clinical Studies (14)] . If a mutation that leads to MET exon 14 skipping is not detected in a plasma specimen, test tumor tissue if feasible. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dosage The recommended dosage of TABRECTA is 400 mg orally twice daily with or without food. Swallow TABRECTA tablets whole. Do not break, crush or chew the tablets. If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time. 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for the management of adverse reactions are listed in Table 1. Table 1: Recommended TABRECTA Dose Reductions for Adverse Reactions Dose reduction Dose and schedule First 300 mg orally twice daily Second 200 mg orally twice daily Permanently discontinue TABRECTA in patients who are unable to tolerate 200 mg orally twice daily. The recommended dosage modifications of TABRECTA for adverse reactions are provided in Table 2. Table 2: Recommended TABRECTA Dosage Modifications for Adverse Reactions Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal. Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse reaction Severity Dosage modification Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1)] Any grade Permanently discontinue TABRECTA. Increased ALT and/or AST without increased total bilirubin [see Warnings and Precautions (5.2)] Grade 3 Withhold TABRECTA until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise resume TABRECTA at a reduced dose. Grade 4 Permanently discontinue TABRECTA. Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis [see Warnings and Precautions (5.2)] ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN Permanently discontinue TABRECTA. Increased total bilirubin without concurrent increased ALT and/or AST [see Warnings and Precautions (5.2)] Grade 2 Withhold TABRECTA until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise resume TABRECTA at a reduced dose. Grade 3 Withhold TABRECTA until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TABRECTA at a reduced dose; otherwise permanently discontinue TABRECTA. Grade 4 Permanently discontinue TABRECTA. Increased lipase or amylase [see Warnings and Precautions (5.3)] Grade 3 Withhold TABRECTA until ≤ Grade 2 or baseline. If recovered to baseline or ≤ Grade 2 within 14 days, resume TABRECTA at a reduced dose; otherwise permanently discontinue TABRECTA. Grade 4 Permanently discontinue TABRECTA. Pancreatitis [see Warnings and Precautions (5.3)] Grade 3 or Grade 4 Permanently discontinue TABRECTA. Hypersensitivity [see Warnings and Precautions (5.4)] All Grades If hypersensitivity is suspected based on clinical judgment, withhold TABRECTA until resolution of the event. Permanently discontinue TABRECTA in patients who develop serious hypersensitivity reactions. Other adverse reactions [see Adverse Reactions (6.1)] Grade 2 Maintain dose level. If intolerable, consider withholding TABRECTA until resolved, then resume TABRECTA at a reduced dose. Grade 3 Withhold TABRECTA until resolved, then resume TABRECTA at a reduced dose. Grade 4 Permanently discontinue TABRECTA."],"spl_product_data_elements":["TABRECTA capmatinib CAPMATINIB HYDROCHLORIDE CAPMATINIB SILICON DIOXIDE CROSPOVIDONE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM LAURYL SULFATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYPROMELLOSES POLYETHYLENE GLYCOL 400 TALC TITANIUM DIOXIDE Pale orange brown ovaloid, curved DU;NVR TABRECTA capmatinib CAPMATINIB HYDROCHLORIDE CAPMATINIB SILICON DIOXIDE CROSPOVIDONE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM LAURYL SULFATE FERRIC OXIDE YELLOW HYPROMELLOSES POLYETHYLENE GLYCOL 400 TALC TITANIUM DIOXIDE ovaloid, curved LO;NVR"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Tablets: 150 mg: pale orange brown, ovaloid, curved film-coated with beveled edges, unscored, debossed with ‘DU’ on one side and ‘NVR’ on the other side 200 mg: yellow, ovaloid, curved film-coated with beveled edges, unscored, debossed with ‘LO’ on one side and ‘NVR’ on the other side Tablets: 150 mg and 200 mg"],"spl_patient_package_insert":["This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: March 2025 PATIENT INFORMATION TABRECTA ® (ta brek tah) (capmatinib) tablets What is TABRECTA? TABRECTA is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that: has spread to other parts of the body (metastatic), and whose tumors have an abnormal mesenchymal epithelial transition (MET) gene. Your healthcare provider will perform a test to make sure that TABRECTA is right for you. It is not known if TABRECTA is safe and effective in children. Before taking TABRECTA, tell your healthcare provider about all of your medical conditions, including if you: have or have had lung or breathing problems other than your lung cancer have or have had liver problems have or have had pancreatic problems are pregnant or plan to become pregnant. TABRECTA can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start your treatment with TABRECTA. You should use effective birth control during treatment and for 1 week after your last dose of TABRECTA. Talk to your healthcare provider about birth control choices that might be right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TABRECTA. Males who have female partners who can become pregnant: You should use effective birth control during treatment and for 1 week after your last dose of TABRECTA. are breastfeeding or plan to breastfeed. It is not known if TABRECTA passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of TABRECTA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take TABRECTA? Take TABRECTA exactly as your healthcare provider tells you. Take TABRECTA 2 times a day with or without food. Swallow TABRECTA tablets whole. Do not break, crush, or chew TABRECTA tablets. Do not change your dose or stop taking TABRECTA unless your healthcare provider tells you to. If you miss or vomit a dose of TABRECTA, do not make up the dose. Take your next dose at your regular scheduled time. What should I avoid while taking TABRECTA? Your skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Use sunscreen or wear clothes that cover your skin during your treatment with TABRECTA to limit direct sunlight exposure. What are the possible side effects of TABRECTA? TABRECTA may cause serious side effects, including: Lung or breathing problems. TABRECTA may cause inflammation of the lungs that can cause death. Tell your healthcare provider right away if you develop any new or worsening symptoms, including: ◦ cough ◦ fever ◦ trouble breathing or shortness of breath Liver problems. TABRECTA may cause abnormal liver blood test results. Your healthcare provider will do blood tests to check your liver function before you start treatment and during treatment with TABRECTA. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including: ◦ your skin or the white part of your eyes turns yellow (jaundice) ◦ dark or “tea-colored” urine ◦ light-colored stools (bowel movements) ◦ confusion ◦ tiredness ◦ loss of appetite for several days or longer ◦ nausea and vomiting ◦ pain, aching, or tenderness on the right side of your stomach-area (abdomen) ◦ weakness ◦ swelling in your stomach-area Pancreas problems . TABRECTA may cause increases in your blood amylase and/or lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your pancreatic function before you start treatment and during treatment with TABRECTA. Tell your healthcare provider right away if you develop any signs and symptoms of pancreas problems, including: upper stomach (abdominal) pain that may spread to your back and get worse with eating weight loss nausea vomiting Allergic reactions. TABRECTA can cause an allergic reaction. Stop taking TABRECTA and tell your healthcare provider right away if you get any signs and symptoms of an allergic reaction, including: ◦ fever ◦ chills ◦ itching ◦ rash ◦ dizziness or feeling faint ◦ nausea ◦ vomiting Risk of sensitivity to sunlight (photosensitivity). See “What should I avoid while taking TABRECTA?” The most common side effects of TABRECTA include: • swelling of your hands or feet • nausea • muscle or bone pain • tiredness and weakness • vomiting • trouble breathing • cough • loss of appetite • changes in certain blood tests Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TABRECTA if you develop certain side effects. These are not all of the possible side effects of TABRECTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store TABRECTA? Store TABRECTA at room temperature between 68°F to 77°F (20°C to 25°C). Store TABRECTA in the original package with the drying agent (desiccant) cartridge. Protect TABRECTA from moisture. Throw away (discard) any unused TABRECTA you have left after 6 weeks of first opening the bottle. Keep TABRECTA and all medicines out of the reach of children. General information about the safe and effective use of TABRECTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TABRECTA for a condition for which it was not prescribed. Do not give TABRECTA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TABRECTA that is written for health professionals. What are the ingredients in TABRECTA? Active ingredient: capmatinib Inactive ingredients: Tablet core: colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate. Tablet coating (150 mg): ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. Tablet coating (200 mg): ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 For more information, go to www.TABRECTA.com or call 1-888-669-6682. © Novartis T2025-11"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , TABRECTA can cause fetal harm when administered to a pregnant woman. There are no available data on TABRECTA use in pregnant women. Oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures less than the human exposure based on AUC at the 400 mg twice daily clinical dose ( see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In rats, maternal toxicity (reduced body weight gain and food consumption) occurred at 30 mg/kg/day (approximately 1.4 times the human exposure based on AUC at the 400 mg twice daily clinical dose). Fetal effects included reduced fetal weights, irregular/incomplete ossification, and increased incidences of fetal malformations (e.g., abnormal flexure/inward malrotation of hindpaws/forepaws, thinness of forelimbs, lack of/reduced flexion at the humerus/ulna joints, and narrowed or small tongue) at doses of ≥ 10 mg/kg/day (approximately 0.6 times the human exposure based on AUC at the 400 mg twice daily clinical dose). In rabbits, no maternal effects were detected at doses up to 60 mg/kg/day (approximately 1.5 times the human exposure based on AUC at the 400 mg twice daily clinical dose). Fetal effects included small lung lobe at ≥ 5 mg/kg/day (approximately 0.016 times the human exposure based on AUC at the 400 mg twice daily clinical dose), and reduced fetal weights, irregular/incomplete ossification and increased incidences of fetal malformations (e.g., abnormal flexure/malrotation of hindpaws/forepaws, thinness of forelimbs/hindlimbs, lack of/reduced flexion at the humerus/ulna joints, small lung lobes, narrowed or small tongue) at the dose of 60 mg/kg/day. 8.2 Lactation Risk Summary There are no data on the presence of capmatinib or its metabolites in either human or animal milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with TABRECTA and for 1 week after the last dose. 8.3 Females and Males of Reproductive Potential Based on animal data, TABRECTA can cause malformations at doses less than the human exposure based on AUC at the 400 mg twice daily clinical dose [see Use in Specific Populations (8.1)] . Pregnancy Testing Verify pregnancy status for females of reproductive potential prior to starting treatment with TABRECTA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. 8.4 Pediatric Use Safety and effectiveness of TABRECTA in pediatric patients have not been established. 8.5 Geriatric Use In GEOMETRY mono-1, 61% of the 373 patients were 65 years or older and 18% were 75 years or older. No overall differences in the safety or effectiveness were observed between these patients and younger patients. 8.6 Renal Impairment No dosage adjustment is recommended in patients with mild (baseline creatinine clearance [CLcr] 60 to 89 mL/min by Cockcroft-Gault) or moderate renal impairment (CLcr 30 to 59 mL/min) [see Clinical Pharmacology (12.3)] . TABRECTA has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min)."],"dosage_and_administration_table":["
Table 1: Recommended TABRECTA Dose Reductions for Adverse Reactions
Dose reductionDose and schedule
First300 mg orally twice daily
Second200 mg orally twice daily
","
Table 2: Recommended TABRECTA Dosage Modifications for Adverse Reactions
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal. Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Adverse reactionSeverityDosage modification
Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1)]Any gradePermanently discontinue TABRECTA.
Increased ALT and/or AST without increased total bilirubin [see Warnings and Precautions (5.2)]Grade 3Withhold TABRECTA until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise resume TABRECTA at a reduced dose.
Grade 4Permanently discontinue TABRECTA.
Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis [see Warnings and Precautions (5.2)]ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULNPermanently discontinue TABRECTA.
Increased total bilirubin without concurrent increased ALT and/or AST [see Warnings and Precautions (5.2)]Grade 2Withhold TABRECTA until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise resume TABRECTA at a reduced dose.
Grade 3Withhold TABRECTA until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TABRECTA at a reduced dose; otherwise permanently discontinue TABRECTA.
Grade 4Permanently discontinue TABRECTA.
Increased lipase or amylase [see Warnings and Precautions (5.3)]Grade 3Withhold TABRECTA until ≤ Grade 2 or baseline. If recovered to baseline or ≤ Grade 2 within 14 days, resume TABRECTA at a reduced dose; otherwise permanently discontinue TABRECTA.
Grade 4Permanently discontinue TABRECTA.
Pancreatitis [see Warnings and Precautions (5.3)]Grade 3 or Grade 4Permanently discontinue TABRECTA.
Hypersensitivity [see Warnings and Precautions (5.4)]All GradesIf hypersensitivity is suspected based on clinical judgment, withhold TABRECTA until resolution of the event. Permanently discontinue TABRECTA in patients who develop serious hypersensitivity reactions.
Other adverse reactions [see Adverse Reactions (6.1)]Grade 2Maintain dose level. If intolerable, consider withholding TABRECTA until resolved, then resume TABRECTA at a reduced dose.
Grade 3Withhold TABRECTA until resolved, then resume TABRECTA at a reduced dose.
Grade 4Permanently discontinue TABRECTA.
"],"spl_patient_package_insert_table":["
This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: March 2025
PATIENT INFORMATION TABRECTA® (ta brek tah) (capmatinib) tablets
What is TABRECTA? TABRECTA is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that: has spread to other parts of the body (metastatic), andwhose tumors have an abnormal mesenchymal epithelial transition (MET) gene. Your healthcare provider will perform a test to make sure that TABRECTA is right for you.It is not known if TABRECTA is safe and effective in children.
Before taking TABRECTA, tell your healthcare provider about all of your medical conditions, including if you:have or have had lung or breathing problems other than your lung cancerhave or have had liver problemshave or have had pancreatic problemsare pregnant or plan to become pregnant. TABRECTA can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start your treatment with TABRECTA.You should use effective birth control during treatment and for 1 week after your last dose of TABRECTA. Talk to your healthcare provider about birth control choices that might be right for you during this time.Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TABRECTA.Males who have female partners who can become pregnant: You should use effective birth control during treatment and for 1 week after your last dose of TABRECTA.are breastfeeding or plan to breastfeed. It is not known if TABRECTA passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of TABRECTA.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take TABRECTA?Take TABRECTA exactly as your healthcare provider tells you.Take TABRECTA 2 times a day with or without food.Swallow TABRECTA tablets whole. Do not break, crush, or chew TABRECTA tablets.Do not change your dose or stop taking TABRECTA unless your healthcare provider tells you to.If you miss or vomit a dose of TABRECTA, do not make up the dose. Take your next dose at your regular scheduled time.
What should I avoid while taking TABRECTA?Your skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Use sunscreen or wear clothes that cover your skin during your treatment with TABRECTA to limit direct sunlight exposure.
What are the possible side effects of TABRECTA? TABRECTA may cause serious side effects, including:Lung or breathing problems. TABRECTA may cause inflammation of the lungs that can cause death. Tell your healthcare provider right away if you develop any new or worsening symptoms, including:
◦ cough ◦ fever ◦ trouble breathing or shortness of breath
Liver problems. TABRECTA may cause abnormal liver blood test results. Your healthcare provider will do blood tests to check your liver function before you start treatment and during treatment with TABRECTA. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
◦ your skin or the white part of your eyes turns yellow (jaundice) ◦ dark or “tea-colored” urine ◦ light-colored stools (bowel movements) ◦ confusion ◦ tiredness ◦ loss of appetite for several days or longer ◦ nausea and vomiting ◦ pain, aching, or tenderness on the right side of your stomach-area (abdomen) ◦ weakness ◦ swelling in your stomach-area
Pancreas problems. TABRECTA may cause increases in your blood amylase and/or lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your pancreatic function before you start treatment and during treatment with TABRECTA. Tell your healthcare provider right away if you develop any signs and symptoms of pancreas problems, including: upper stomach (abdominal) pain that may spread to your back and get worse with eatingweight lossnauseavomiting
Allergic reactions. TABRECTA can cause an allergic reaction. Stop taking TABRECTA and tell your healthcare provider right away if you get any signs and symptoms of an allergic reaction, including:
◦ fever ◦ chills ◦ itching ◦ rash ◦ dizziness or feeling faint ◦ nausea ◦ vomiting
Risk of sensitivity to sunlight (photosensitivity). See “What should I avoid while taking TABRECTA?”
The most common side effects of TABRECTA include:
• swelling of your hands or feet • nausea • muscle or bone pain • tiredness and weakness • vomiting • trouble breathing • cough • loss of appetite • changes in certain blood tests
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TABRECTA if you develop certain side effects. These are not all of the possible side effects of TABRECTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store TABRECTA?Store TABRECTA at room temperature between 68°F to 77°F (20°C to 25°C).Store TABRECTA in the original package with the drying agent (desiccant) cartridge.Protect TABRECTA from moisture.Throw away (discard) any unused TABRECTA you have left after 6 weeks of first opening the bottle.Keep TABRECTA and all medicines out of the reach of children.
General information about the safe and effective use of TABRECTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TABRECTA for a condition for which it was not prescribed. Do not give TABRECTA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TABRECTA that is written for health professionals.
What are the ingredients in TABRECTA? Active ingredient: capmatinib Inactive ingredients: Tablet core: colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate. Tablet coating (150 mg): ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. Tablet coating (200 mg): ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 For more information, go to www.TABRECTA.com or call 1-888-669-6682. © Novartis
"],"animal_pharmacology_and_or_toxicology":["13.2 Animal Toxicology and/or Pharmacology In rats, capmatinib administration resulted in vacuolation of white matter of the brain in both 4- and 13-week studies at doses ≥ 2.2 times the human exposure (AUC) at the 400 mg twice daily clinical dose. In some cases, the brain lesions were associated with early death and/or convulsions or tremors. Concentrations of capmatinib in the brain tissue of rats was approximately 9% of the corresponding concentrations in plasma. In vitro and in vivo assays demonstrated that capmatinib has some potential for photosensitization; however, the no-observed-adverse-effect level for in vivo photosensitization was 30 mg/kg/day (C max of 14000 ng/mL), about 2.9 times the human C max at the 400 mg twice daily clinical dose."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 0078-0709-56 TABRECTA ® (capmatinib) tablets 150 mg * Attention: Dispense and store Tabrecta in original container with the desiccant to protect from moisture. Rx only 56 Film-coated tablets NOVARTIS PRINCIPAL DISPLAY PANEL NDC 0078-0709-56 TABRECTA® (capmatinib) tablets 150 mg* Attention: Dispense and store Tabrecta in original container with the desiccant to protect from moisture. Rx only 56 Film-coated tablets NOVARTIS","PRINCIPAL DISPLAY PANEL NDC 0078-0716-56 TABRECTA ® (capmatinib) tablets 200 mg * Attention: Dispense and store Tabrecta in original container with the desiccant to protect from moisture. Rx only 56 Film-coated tablets NOVARTIS PRINCIPAL DISPLAY PANEL NDC 0078-0716-56 TABRECTA® (capmatinib) tablets 200 mg* Attention: Dispense and store Tabrecta in original container with the desiccant to protect from moisture. Rx only 56 Film-coated tablets NOVARTIS"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies were not conducted with capmatinib. Capmatinib was not mutagenic in an in vitro bacterial reverse mutation assay and did not cause chromosomal aberrations in an in vitro chromosome aberration assay in human peripheral blood lymphocytes. Capmatinib was not clastogenic in an in vivo bone marrow micronucleus test in rats. Dedicated fertility studies were not conducted with capmatinib. No effects on male and female reproductive organs occurred in general toxicology studies conducted in rats and monkeys at doses resulting in exposures of up to approximately 3.6 times the human exposure based on AUC at the 400 mg twice daily clinical dose."]},"tags":[{"label":"Kinase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Hepatocyte growth factor receptor","category":"target"},{"label":"MET","category":"gene"},{"label":"CDKL5","category":"gene"},{"label":"L01EX17","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Metastatic non-small cell lung cancer","category":"indication"},{"label":"Novartis Pharm","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"409 reports"},{"date":"","signal":"PERIPHERAL SWELLING","source":"FDA FAERS","actionTaken":"286 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"257 reports"},{"date":"","signal":"OEDEMA PERIPHERAL","source":"FDA FAERS","actionTaken":"242 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"239 reports"},{"date":"","signal":"MALIGNANT NEOPLASM PROGRESSION","source":"FDA FAERS","actionTaken":"178 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"135 reports"},{"date":"","signal":"OEDEMA","source":"FDA FAERS","actionTaken":"131 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"112 reports"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"98 reports"}],"commonSideEffects":[{"effect":"Peripheral edema","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Nausea","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Fatigue","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Vomiting","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Dyspnea","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Decreased appetite","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Pneumonia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Pleural effusion","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"General physical health deterioration","drugRate":"3%","severity":"common","_validated":true},{"effect":"Peripheral swelling","drugRate":"2.9%","severity":"common","_validated":true},{"effect":"Fluid overload","drugRate":"2.9%","severity":"common","_validated":true},{"effect":"Increased blood creatinine","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased lipase","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased ALT","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased amylase","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased AST","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased blood bilirubin","drugRate":"2%","severity":"common","_validated":true},{"effect":"Pneumonitis","drugRate":"1.3%","severity":"mild","_validated":true}],"specialPopulations":{"Lactation":"There are no data on the presence of capmatinib or its metabolites in either human or animal milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with TABRECTA and for week after the last dose.","Pregnancy":"TABRECTA can cause fetal harm when administered to pregnant woman. There are no available data on TABRECTA use in pregnant women. Oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures less than the human exposure based on AUC at the 400 mg twice daily clinical dose. Advise pregnant women of the potential risk to fetus.","Geriatric use":"In GEOMETRY mono-1, 57% of the 334 patients were 65 years or older and 16% were 75 years or older. No overall differences in the safety or effectiveness were observed between these patients and younger patients.","Paediatric use":"Safety and effectiveness of TABRECTA in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Novartis Pharm","patents":[{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"Nov 19, 2027","useCode":"U-2813","territory":"US","drugProduct":false,"patentNumber":"12084449","drugSubstance":false},{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"May 20, 2029","useCode":"U-2813","territory":"US","drugProduct":false,"patentNumber":"8901123","drugSubstance":false},{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"Jun 5, 2031","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8420645","drugSubstance":true},{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"Jul 22, 2035","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10596178","drugSubstance":false},{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"Nov 19, 2032","useCode":"","territory":"US","drugProduct":true,"patentNumber":"7767675","drugSubstance":true},{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"Nov 19, 2027","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8461330","drugSubstance":true},{"applNo":"N213591","source":"FDA Orange Book","status":"Active","expires":"Jul 22, 2035","useCode":"","territory":"US","drugProduct":true,"patentNumber":"12208101","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CAPMATINIB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:33:22.204941+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T02:33:20.180866+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Capmatinib","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:33:31.289531+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T02:33:52.459963+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:33:29.739349+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T02:33:22.228862+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T02:33:18.662997+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CAPMATINIB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:33:30.710181+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:33:17.708047+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:33:44.873091+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:33:17.708093+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T02:33:32.223288+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Hepatocyte growth factor receptor inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:33:31.289264+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989937/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:33:31.179980+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA213591","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:33:17.708101+00:00"}},"allNames":"tabrecta","offLabel":[],"synonyms":["capmatinib","capmatinib hydrochloride","capmatinib hydrochloride hydrate","tabrecta","NVP-INC280-NX","INC280","INCB-028060","vcapmatinib dihydrochloride monohydrate"],"timeline":[{"date":"2020-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from NOVARTIS PHARM to Novartis Pharm"},{"date":"2020-05-06","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novartis Pharm)"},{"date":"2020-06-29","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Novartis Pharma K.K.)"},{"date":"2022-06-20","type":"positive","source":"DrugCentral","milestone":"EMA approval (Novartis Europharm Limited)"},{"date":"2027-05-06","type":"negative","source":"FDA Orange Book","milestone":"ODE-291 exclusivity expires"},{"date":"2027-11-19","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8461330 expires"},{"date":"2031-06-05","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8420645 expires"},{"date":"2032-11-19","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 7767675 expires"}],"aiSummary":"Capmatinib (Tabrecta), marketed by Novartis, is a targeted therapy for metastatic NSCLC with MET exon 14 skipping, positioning it in a niche but critical segment of the oncology market. Its key strength lies in its mechanism of action, which specifically blocks the hepatocyte growth factor receptor, offering a precise treatment option for this patient population. The primary risk to Capmatinib's market position is the upcoming key patent expiry in 2028, which could lead to increased competition from generics and biosimilars.","brandName":"Tabrecta","ecosystem":[{"indication":"Metastatic non-small cell lung cancer","otherDrugs":[{"name":"atezolizumab","slug":"atezolizumab","company":"Genentech Inc"},{"name":"pralsetinib","slug":"pralsetinib","company":"Blueprint Medicines"},{"name":"selpercatinib","slug":"selpercatinib","company":"Loxo Oncology Inc"},{"name":"tepotinib","slug":"tepotinib","company":"Emd Serono Inc"}],"globalPrevalence":2200000}],"mechanism":{"target":"Hepatocyte growth factor receptor","novelty":"Follow-on","targets":[{"gene":"MET","source":"DrugCentral","target":"Hepatocyte growth factor receptor","protein":"Hepatocyte growth factor receptor"},{"gene":"CDKL5","source":"DrugCentral","target":"Cyclin-dependent kinase-like 5","protein":"Cyclin-dependent kinase-like 5"}],"moaClass":"Breast Cancer Resistance Protein Inhibitors","modality":"Small Molecule","drugClass":"Kinase Inhibitor","explanation":"Capmatinib is kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in protein with missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling. Capmatinib inhibited cancer cell growth driven by mutant MET variant lacking exon 14 at clinically achievable concentrations and demonstrated anti-tumor activity in murine tumor xenograft models derived from human lung tumors with either mutation leading to MET exon 14 skipping or MET amplification. Capmatinib inhibited the phosphorylation of MET triggered by binding of hepatocyte growth factor or by MET amplification, as well as MET-mediated phosphorylation of downstream signaling proteins and proliferation and survival of MET-dependent cancer cells.","oneSentence":"Tabrecta works by blocking the hepatocyte growth factor receptor, a protein that helps cancer cells grow and spread.","technicalDetail":"Tabrecta (Capmatinib) is a potent and selective inhibitor of the mesenchymal-epithelial transition factor (MET) receptor tyrosine kinase, which is involved in the regulation of cell growth, survival, and migration."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Capmatinib","title":"Capmatinib","extract":"Capmatinib, sold under the brand name Tabrecta, is an anticancer medication used for the treatment of metastatic non-small cell lung cancer whose tumors have a mutation that leads to the exon 14 skipping of the MET gene, which codes for the membrane receptor HGFR.","wiki_history":"== History ==\nCapmatinib was approved for medical use in the United States in May 2020, along with the FoundationOne CDx assay as a companion diagnostic for capmatinib.\n\nEfficacy was demonstrated in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multicohort study enrolling 334 participants with metastatic non-small cell lung cancer with confirmed MET exon 14 skipping. Some participants were previously treated for their cancer and some were not (treatment-naïve). Participants received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity. The efficacy was based on results from 97 of the participants. The trial was conducted at 92 sites in the United States, Austria, Belgium, France, Germany, Israel, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Norway, Russia, Singapore, Sweden, Switzerland, Spain, Taiwan and the UK.\n\nThe major efficacy outcome measure was overall response rate (ORR), which reflects the percentage of participants that had a certain amount of tumor shrinkage. An additional efficacy outcome measure was duration of response (DOR). The efficacy population included 28 participants who had never undergone treatment for non-small cell lung cancer and 69 previously treated participants. The ORR for the 28 participants was 68%, with 4% having a complete response and 64% having a partial response. The ORR for the 69 participants was 41%, with all having a partial response. Of the responding participants who had never undergone treatment for non-small cell lung cancer, 47% had a duration of response lasting 12 months or longer compared to 32.1% of the responding participants who had been previously treated.\n\nThe US Food and Drug Administration (FDA) processed the application under the accelerated approval program and granted the application for capmatinib priority review, orphan drug, and breakthrough therapy designations and granted the approval of Tabrecta to Novartis Pharmaceuti","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nIn April 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tabrecta, intended for treatment of people with advanced non-small cell lung cancer harboring alterations leading to MET gene exon 14 (METex14) skipping. Capmatinib was approved for medical use in the European Union in September 2022."},"commercial":{"launchDate":"2020","revenueYear":2024,"_launchSource":"DrugCentral (FDA 2020-05-06, NOVARTIS PHARM)","annualRevenue":200,"revenueSource":"Verified: Novartis AR","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5392","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CAPMATINIB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CAPMATINIB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Capmatinib","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T09:09:10.564496","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T02:33:52.460714+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"sunitinib","drugSlug":"sunitinib","fdaApproval":"2006-01-26","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sorafenib","drugSlug":"sorafenib","fdaApproval":"2005-12-20","patentExpiry":"Sep 10, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"pazopanib","drugSlug":"pazopanib","fdaApproval":"2009-10-19","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"vandetanib","drugSlug":"vandetanib","fdaApproval":"2011-04-06","patentExpiry":"Aug 8, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"regorafenib","drugSlug":"regorafenib","fdaApproval":"2012-09-27","patentExpiry":"Jun 2, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"cabozantinib","drugSlug":"cabozantinib","fdaApproval":"2012-11-29","patentExpiry":"Oct 8, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lenvatinib","drugSlug":"lenvatinib","fdaApproval":"2015-02-13","patentExpiry":"Sep 3, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"nintedanib","drugSlug":"nintedanib","fdaApproval":"2014-10-15","patentExpiry":"Jun 7, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"midostaurin","drugSlug":"midostaurin","fdaApproval":"2017-04-28","patentExpiry":"Oct 9, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"quizartinib","drugSlug":"quizartinib","fdaApproval":"2023-07-20","patentExpiry":"Sep 30, 2033","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"larotrectinib","drugSlug":"larotrectinib","fdaApproval":"2018-11-26","patentExpiry":"Oct 21, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"gilteritinib","drugSlug":"gilteritinib","fdaApproval":"2018-11-28","patentExpiry":"Nov 28, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"entrectinib","drugSlug":"entrectinib","fdaApproval":"2019-08-15","patentExpiry":"May 22, 2033","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"pexidartinib","drugSlug":"pexidartinib","fdaApproval":"2019-08-02","patentExpiry":"Nov 21, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"avapritinib","drugSlug":"avapritinib","fdaApproval":"2020-01-09","patentExpiry":"Oct 15, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ripretinib","drugSlug":"ripretinib","fdaApproval":"2020-05-15","patentExpiry":"Oct 6, 2042","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tepotinib","drugSlug":"tepotinib","fdaApproval":"2021-02-03","patentExpiry":"Oct 30, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"selpercatinib","drugSlug":"selpercatinib","fdaApproval":"2020-05-08","patentExpiry":"Oct 10, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"pralsetinib","drugSlug":"pralsetinib","fdaApproval":"2020-09-04","patentExpiry":"Nov 1, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"umbralisib","drugSlug":"umbralisib","fdaApproval":"2021-02-05","patentExpiry":"May 26, 2035","patentStatus":"Patent protected","relationship":"same-class"}],"exclusivity":[{"code":"ODE-291","date":"May 6, 2027"},{"code":"ODE-291","date":"May 6, 2027"}],"genericName":"capmatinib","indications":{"approved":[{"id":"capmatinib-metastatic-nsclc-with-met-exon","name":"Metastatic NSCLC with MET exon 14 skipping","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult patients with metastatic non-small cell lung cancer (NSCLC)","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult patients with metastatic non-small cell lung cancer (NSCLC)","diagnosticRequired":"MET exon 14 skipping mutation detected by an FDA-approved test","brandNameForIndication":"Tabrecta"}],"offLabel":[],"pipeline":[]},"currentOwner":"Novartis Pharm","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"sunitinib","brandName":"sunitinib","genericName":"sunitinib","approvalYear":"2006","relationship":"same-class"},{"drugId":"sorafenib","brandName":"sorafenib","genericName":"sorafenib","approvalYear":"2005","relationship":"same-class"},{"drugId":"pazopanib","brandName":"pazopanib","genericName":"pazopanib","approvalYear":"2009","relationship":"same-class"},{"drugId":"vandetanib","brandName":"vandetanib","genericName":"vandetanib","approvalYear":"2011","relationship":"same-class"},{"drugId":"regorafenib","brandName":"regorafenib","genericName":"regorafenib","approvalYear":"2012","relationship":"same-class"},{"drugId":"cabozantinib","brandName":"cabozantinib","genericName":"cabozantinib","approvalYear":"2012","relationship":"same-class"},{"drugId":"lenvatinib","brandName":"lenvatinib","genericName":"lenvatinib","approvalYear":"2015","relationship":"same-class"},{"drugId":"nintedanib","brandName":"nintedanib","genericName":"nintedanib","approvalYear":"2014","relationship":"same-class"},{"drugId":"midostaurin","brandName":"midostaurin","genericName":"midostaurin","approvalYear":"2017","relationship":"same-class"},{"drugId":"quizartinib","brandName":"quizartinib","genericName":"quizartinib","approvalYear":"2023","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04677595","phase":"PHASE2","title":"Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-05-17","conditions":["Non-Small Cell Lung Cancer (NSCLC)"],"enrollment":36,"completionDate":"2025-05-22"},{"nctId":"NCT04741789","phase":"","title":"Managed Access Programs for INC280, Capmatinib","status":"NO_LONGER_AVAILABLE","sponsor":"Novartis Pharmaceuticals","startDate":"","conditions":["Non-Small Cell Lung Cancer"],"enrollment":0,"completionDate":""},{"nctId":"NCT05488314","phase":"PHASE1,PHASE2","title":"A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2022-12-13","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":57,"completionDate":"2027-04-28"},{"nctId":"NCT03040973","phase":"PHASE2","title":"Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2017-08-23","conditions":["Advanced Solid Tumors Which Are cMET-dependent"],"enrollment":29,"completionDate":"2027-07-30"},{"nctId":"NCT02813135","phase":"PHASE1,PHASE2","title":"European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors","status":"RECRUITING","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","startDate":"2016-08-03","conditions":["Pediatric Cancer"],"enrollment":472,"completionDate":"2031-02"},{"nctId":"NCT03333343","phase":"PHASE1","title":"Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2018-01-29","conditions":["EGFR-mutant Non-small Cell Lung Cancer"],"enrollment":105,"completionDate":"2026-10-05"},{"nctId":"NCT03784014","phase":"PHASE3","title":"Molecular Profiling of Advanced Soft-tissue Sarcomas","status":"ACTIVE_NOT_RECRUITING","sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","startDate":"2019-10-19","conditions":["Soft Tissue Sarcoma"],"enrollment":603,"completionDate":"2026-01-13"},{"nctId":"NCT05642572","phase":"PHASE2","title":"Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)","status":"RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2023-05-05","conditions":["Recurrent Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8"],"enrollment":66,"completionDate":"2027-05-31"},{"nctId":"NCT05110196","phase":"PHASE4","title":"Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2022-09-03","conditions":["Non-Small Cell Lung Carcinoma"],"enrollment":50,"completionDate":"2025-08-04"},{"nctId":"NCT06988475","phase":"PHASE2,PHASE3","title":"DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","status":"RECRUITING","sponsor":"Cancer Research UK","startDate":"2024-11-19","conditions":["Solid Tumour","Haematological Malignancy","Malignant Neoplasm","Neoplasms by Histologic Type","Neoplasms by Site","Cancer","Malignancy","Glioma","Neuroblastoma","Gastric Cancer","Soft Tissue Sarcoma"],"enrollment":30,"completionDate":"2029-10"},{"nctId":"NCT05722886","phase":"PHASE2,PHASE3","title":"DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol","status":"RECRUITING","sponsor":"Cancer Research UK","startDate":"2023-03-01","conditions":["Haematological Malignancy","Solid Tumour"],"enrollment":825,"completionDate":"2029-10"},{"nctId":"NCT04926831","phase":"PHASE2","title":"Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2022-08-10","conditions":["Non-small Cell Lung Cancer"],"enrollment":4,"completionDate":"2024-03-13"},{"nctId":"NCT04575025","phase":"","title":"Special Drug Use-results Surveillance of Tabrecta Tablets","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-11-02","conditions":["Non-small Cell Lung Cancer"],"enrollment":109,"completionDate":"2024-10-26"},{"nctId":"NCT05243641","phase":"PHASE1,PHASE2","title":"Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-08-18","conditions":["Metastatic Breast Cancer","Breast Cancer"],"enrollment":10,"completionDate":"2024-11-19"},{"nctId":"NCT03742349","phase":"PHASE1","title":"Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2019-01-31","conditions":["Triple Negative Breast Cancer (TNBC)"],"enrollment":64,"completionDate":"2023-02-06"},{"nctId":"NCT04427072","phase":"PHASE3","title":"Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-09-25","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":22,"completionDate":"2023-11-06"},{"nctId":"NCT05703516","phase":"","title":"A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2023-06-12","conditions":["Non-Small-Cell Lung Carcinoma"],"enrollment":250,"completionDate":"2026-10-31"},{"nctId":"NCT04139317","phase":"PHASE2","title":"Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-01-22","conditions":["Non-small Cell Lung Cancer (NSCLC)"],"enrollment":76,"completionDate":"2023-02-07"},{"nctId":"NCT04323436","phase":"PHASE2","title":"Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-08-19","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":31,"completionDate":"2023-01-26"},{"nctId":"NCT01737827","phase":"PHASE2","title":"Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2013-03-25","conditions":["Advanced Hepatocellular Carcinoma With c-MET Dysregulation"],"enrollment":38,"completionDate":"2023-05-24"},{"nctId":"NCT03192501","phase":"","title":"iCAGES-guided Precision Therapy for Cancers in Contrast to Standard Care or IHC-guided Theray","status":"RECRUITING","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","startDate":"2017-07-01","conditions":["Lung Cancer","Gene Abnormality","Gene Product Sequence Variation","Cancer"],"enrollment":250,"completionDate":"2039-07-01"},{"nctId":"NCT03484923","phase":"PHASE2","title":"Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-09-10","conditions":["Melanoma"],"enrollment":196,"completionDate":"2022-12-30"},{"nctId":"NCT05567055","phase":"PHASE2","title":"Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations","status":"WITHDRAWN","sponsor":"Timothy Burns, MD, PHD","startDate":"2023-10-03","conditions":["Non-small Cell Lung Cancer"],"enrollment":0,"completionDate":"2028-09"},{"nctId":"NCT05435846","phase":"PHASE1","title":"Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation","status":"TERMINATED","sponsor":"Collin Blakely","startDate":"2022-08-10","conditions":["Metastatic Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer"],"enrollment":3,"completionDate":"2024-05-31"},{"nctId":"NCT02414139","phase":"PHASE2","title":"Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":true,"startDate":"2015-06-11","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":373,"completionDate":"2023-05-16"},{"nctId":"NCT04816214","phase":"PHASE3","title":"Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-09-22","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":6,"completionDate":"2022-12-27"},{"nctId":"NCT02159066","phase":"PHASE2","title":"LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-07-23","conditions":["Melanoma"],"enrollment":158,"completionDate":"2023-01-10"},{"nctId":"NCT04817956","phase":"PHASE2","title":"Improving Public Cancer Care by Implementing Precision Medicine in Norway","status":"RECRUITING","sponsor":"Oslo University Hospital","startDate":"2021-04-01","conditions":["Cancer Metastatic"],"enrollment":3000,"completionDate":"2045-04-30"},{"nctId":"NCT06161051","phase":"","title":"Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2022-10-03","conditions":["Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation"],"enrollment":287,"completionDate":"2022-12-07"},{"nctId":"NCT06054191","phase":"PHASE2","title":"Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-02-01","conditions":["NSCLC","BRAF V600 Mutation","MET Exon 14 Mutation"],"enrollment":40,"completionDate":"2027-03-01"},{"nctId":"NCT02386826","phase":"PHASE1","title":"INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme","status":"COMPLETED","sponsor":"SCRI Development Innovations, LLC","startDate":"2015-09-22","conditions":["Glioblastoma Multiforme","Gliosarcoma","Colorectal Cancer","Renal Cell Carcinoma"],"enrollment":65,"completionDate":"2023-08-23"},{"nctId":"NCT02795429","phase":"PHASE1,PHASE2","title":"Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-06-15","conditions":["Advanced Hepatocellular Carcinoma"],"enrollment":89,"completionDate":"2021-06-24"},{"nctId":"NCT02335944","phase":"PHASE1,PHASE2","title":"Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-01-13","conditions":["Non Small Cell Lung Cancer"],"enrollment":177,"completionDate":"2020-11-10"},{"nctId":"NCT05796726","phase":"","title":"Retrospective Chart Review and Historical Comparison of Capmatinib vs. Standard of Care for German Adult Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring METex14 Mutations","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-12-10","conditions":["Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations"],"enrollment":260,"completionDate":"2022-03-22"},{"nctId":"NCT02019693","phase":"PHASE2","title":"A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2014-01-24","conditions":["Kidney Cancer"],"enrollment":20,"completionDate":"2021-12-17"},{"nctId":"NCT05135845","phase":"PHASE2","title":"Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma","status":"SUSPENDED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-03-22","conditions":["Oesophageal Adenocarcinoma","Gastric Adenocarcinoma"],"enrollment":90,"completionDate":"2025-10"},{"nctId":"NCT05675683","phase":"","title":"Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-10-01","conditions":["Metastatic Non-Small Cell Lung Cancer"],"enrollment":68,"completionDate":"2021-12-31"},{"nctId":"NCT05154344","phase":"","title":"RW Effectiveness of Capmatinib in Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)","status":"COMPLETED","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","startDate":"2021-11-29","conditions":["MET Alterations","Non Small Cell Lung Cancer","METex14 Mutations"],"enrollment":182,"completionDate":"2022-02-01"},{"nctId":"NCT02750215","phase":"PHASE2","title":"A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14 Alterations Who Have Received Prior MET Inhibitor","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2016-05","conditions":["Malignant Non-small Cell Neoplasm of Lung Stage IV"],"enrollment":20,"completionDate":"2021-05"},{"nctId":"NCT02323126","phase":"PHASE2","title":"Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-02-09","conditions":["Non Small Cell Lung Cancer"],"enrollment":64,"completionDate":"2021-02-05"},{"nctId":"NCT03647488","phase":"PHASE2","title":"Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-12-26","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":18,"completionDate":"2020-09-07"},{"nctId":"NCT01911507","phase":"PHASE1","title":"INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"University of California, Davis","startDate":"2013-08-27","conditions":["Recurrent Non-small Cell Lung Cancer"],"enrollment":35,"completionDate":"2020-08-26"},{"nctId":"NCT01610336","phase":"PHASE2","title":"A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-04-05","conditions":["Non-small Cell Lung Cancer"],"enrollment":161,"completionDate":"2020-05-27"},{"nctId":"NCT01324479","phase":"PHASE1","title":"Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-02-29","conditions":["Solid Tumors"],"enrollment":131,"completionDate":"2017-07-04"},{"nctId":"NCT02925104","phase":"PHASE1","title":"A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-12-14","conditions":["cMET Dysegulation Advanced Solid Tumors"],"enrollment":36,"completionDate":"2018-05-16"},{"nctId":"NCT01546428","phase":"PHASE1","title":"A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-02","conditions":["Advanced Solid Tumor"],"enrollment":44,"completionDate":"2016-01"},{"nctId":"NCT02276027","phase":"PHASE2","title":"A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-01-20","conditions":["Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma"],"enrollment":66,"completionDate":"2019-10-15"},{"nctId":"NCT02474537","phase":"PHASE1","title":"INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-06-12","conditions":["Hepatic Impairment"],"enrollment":31,"completionDate":"2017-09-12"},{"nctId":"NCT02626234","phase":"PHASE1","title":"A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-12-08","conditions":["cMET-dysregulated Advanced Solid Tumors"],"enrollment":32,"completionDate":"2017-04-28"},{"nctId":"NCT02520752","phase":"PHASE1","title":"A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-12-10","conditions":["cMET-dysregulated Advanced Solid Tumors"],"enrollment":37,"completionDate":"2017-09-12"},{"nctId":"NCT04460729","phase":"PHASE2","title":"A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2020-11-11","conditions":["Non-small Cell Lung Carcinoma (NSCLC)"],"enrollment":0,"completionDate":"2023-11-17"},{"nctId":"NCT02468661","phase":"PHASE1","title":"A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-09-23","conditions":["Non-Small Cell Lung Cancer"],"enrollment":23,"completionDate":"2018-12-05"},{"nctId":"NCT02587650","phase":"PHASE2","title":"Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma","status":"TERMINATED","sponsor":"University of California, San Francisco","startDate":"2015-03-26","conditions":["ALK Fusion Protein Expression","BRAF wt Allele","Invasive Skin Melanoma","MET Fusion Gene Positive","NRAS wt Allele","NTRK1 Fusion Positive","NTRK2 Fusion Positive","NTRK3 Fusion Positive","RET Fusion Positive","ROS1 Fusion Positive","Stage III Cutaneous Melanoma","Stage IIIA Cutaneous Melanoma","Stage IIIB Cutaneous Melanoma","Stage IIIC Cutaneous Melanoma","Stage IV Cutaneous Melanoma"],"enrollment":1,"completionDate":"2018-07-12"},{"nctId":"NCT02205398","phase":"PHASE1","title":"Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-07-28","conditions":["Squamous Cell Carcinoma of Head and Neck (SCCHN)","Metastatic Colorectal Cancer"],"enrollment":13,"completionDate":"2017-01-20"},{"nctId":"NCT03693339","phase":"PHASE2","title":"Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation","status":"UNKNOWN","sponsor":"Asan Medical Center","startDate":"2018-10-30","conditions":["Cancer","Lung Cancer Metastatic","MET Gene Mutation"],"enrollment":27,"completionDate":"2022-06-30"},{"nctId":"NCT03240393","phase":"PHASE2","title":"Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2018-07-31","conditions":["Carcinoma","Non-Small-Cell Lung Cancer"],"enrollment":0,"completionDate":"2021-10-26"},{"nctId":"NCT01870726","phase":"PHASE1,PHASE2","title":"Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-01-09","conditions":["c-MET Inhibitor; PI3K Inhibitor, PTEN Mutations, Homozygous Del. of PTEN or PTEN Neg. by IHC, c-Met Ampli. by FISH, INC280, BKM120, Buparlisib; Recurrent GBM"],"enrollment":43,"completionDate":"2016-12-23"},{"nctId":"NCT01072266","phase":"PHASE1","title":"A Dose-escalation Study in Subjects With Advanced Malignancies","status":"COMPLETED","sponsor":"Incyte Corporation","startDate":"2010-01","conditions":["Solid Tumor","Advanced Cancer","Metastatic Cancer"],"enrollment":45,"completionDate":"2013-01"},{"nctId":"NCT01820364","phase":"PHASE2","title":"LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma","status":"TERMINATED","sponsor":"Array BioPharma","startDate":"2013-11","conditions":["Melanoma"],"enrollment":15,"completionDate":"2015-03"},{"nctId":"NCT01964235","phase":"PHASE2","title":"Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2016-12","conditions":["Advanced Hepatocellular Carcinoma"],"enrollment":0,"completionDate":"2019-07"}],"_emaApprovals":[{"date":"2022-06-20","status":"Authorised","company":"NOVARTIS EUROPHARM LIMITED"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT02414139"],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET, FILM COATED","route":"ORAL","productName":"TABRECTA"}]},"_patentsChecked":true,"crossReferences":{"MMSL":"334138","NDDF":"018358","UNII":"TY34L4F9OZ","VANDF":"4039388","INN_ID":"9948","RXNORM":"2362165","UMLSCUI":"C4053698","chemblId":"CHEMBL3989937","ChEMBL_ID":"CHEMBL3188267","KEGG_DRUG":"D10696","DRUGBANK_ID":"DB11791","PUBCHEM_CID":"25145656","SNOMEDCT_US":"874907006","IUPHAR_LIGAND_ID":"7904","SECONDARY_CAS_RN":"1865733-40-9","MESH_SUPPLEMENTAL_RECORD_UI":"C000613976"},"formularyStatus":[],"originalProduct":{"form":"TABLET, FILM COATED","route":"ORAL","company":"Novartis Pharmaceuticals Corporation","brandName":"TABRECTA","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2020-","companyName":"Novartis Pharm","relationship":"Original Developer"},{"period":"2020","companyName":"Novartis Pharma K.K.","relationship":"PMDA Licensee"},{"period":"2022","companyName":"Novartis Europharm Limited","relationship":"EMA Licensee"}],"pharmacokinetics":{"source":"FDA label","halfLife":"6.5 hours"},"publicationCount":294,"therapeuticAreas":["Oncology"],"_revenueScrapedAt":"2026-04-08 13:58:57.844131+00","atcClassification":{"source":"DrugCentral","atcCode":"L01EX17","allCodes":["L01EX17"]},"biosimilarFilings":[],"originalDeveloper":"Novartis Pharm","recentPublications":[{"date":"2026 Apr","pmid":"41654096","title":"Real-world evidence for 10 oncology drugs approved in the last 5 years: A comprehensive narrative synthesis.","journal":"Critical reviews in oncology/hematology"},{"date":"2026 Feb","pmid":"41617462","title":"Clinical Activity of MET-TKIs in METex14 Skipping NSCLC With Poor Performance Status.","journal":"Anticancer research"},{"date":"2026 Jan 8","pmid":"41595127","title":"Targeting Mesenchymal-Epidermal Transition (MET) Aberrations in Non-Small Cell Lung Cancer: Current Challenges and Therapeutic Advances.","journal":"Cancers"},{"date":"2026 Dec","pmid":"41582009","title":"A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk.","journal":"Renal failure"},{"date":"2025 Dec","pmid":"41573491","title":"Safety and Synergy of Capmatinib Plus Stereotactic Radiotherapy in MET Exon 14-Mutated Non-Small Cell Lung Cancer: A Case Report.","journal":"Cureus"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Novartis Pharm","companyId":"novartis","modality":"Small molecule","firstApprovalDate":"2020","enrichmentLevel":4,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-03-14T00:00:00.000Z","mah":"NOVARTIS PHARM","brand_name_local":null,"application_number":"NDA213591"},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":9,"withResults":3},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T02:33:52.460714+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}